Drugs

Pro-generic Group Seeks Legislation to Curb Brand Abuses

A group of healthcare stakeholders is urging the Senate Special Committee on Aging to take up legislation to curb the increasing use of restricted access programs by brand drug makers to block generic entry into the market. In a recent letter to committee leaders, the stakeholders complain that some brand companies have used FDA-mandated Risk Evaluation and Mitigation Strategies (REMS) restricted-distribution programs to deny manufacturers of generics and biosimilars access to product samples they need to obtain agency approval.

The stakeholders recommend a House of Representatives bill called the Fair Access for Safe and Timely (FAST) Generics Act (H.R. 2841) as model legislation for the Senate to consider. “The bill would establish clear processes that would facilitate the provision of product samples to generic manufacturers and prevent companies from denying the implementation of shared REMS programs,” according to the letter. “The bill also defines certain anticompetitive practices with respect to restricted access programs, thus closing the existing loophole around current REMS prohibitions.”

Rasonque OK’d Across KRAS Mutations Despite Clinical Response Differences

FDA granted approval to Revolution Medicines' Rasonque (daraxonrasib) for metastatic pancreatic cancer despite substantial differences in treatment responses among patients with different KRAS mutations and limited evidence of effectiveness in patients without RAS mutations, according to a newly released approval document. The 321-page review shows that FDA considered

FDA Safety Concerns Complicate Plan to Expand Peptide Compounding

The Trump Administration is developing a temporary policy that would allow compounding pharmacies to dispense certain unapproved peptides despite earlier FDA scientific assessments finding insufficient evidence of their safety and effectiveness, setting up a potential conflict between administration policy and the agency's scientific reviewers. Federal officials are considering

DoJ Enforcement Directive Signals More Scrutiny of FDA-Regulated Firms

A new Department of Justice directive identifying violations of the Federal Food, Drug, and Cosmetic Act (FDCA) among potential targets for fraud enforcement could expose FDA-regulated firms to increased federal investigations and criminal prosecutions, according to an analysis by attorneys at Holland & Knight. The 10/1 directive outlines

Guide on Biosimilar Postapproval Manufacturing Changes

FDA has released a final guidance entitled “Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products — Questions and Answers.” The document explains how manufacturers should document and report changes to approved biosimilars, including changes involving manufacturing processes, production facilities, dosage forms and strengths. Regarding information required for postapproval manufacturing changes,

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Rasonque OK’d Across KRAS Mutations Despite Clinical Response Differences

FDA Safety Concerns Complicate Plan to Expand Peptide Compounding

DoJ Enforcement Directive Signals More Scrutiny of FDA-Regulated Firms

Guide on Biosimilar Postapproval Manufacturing Changes